Antibiotics Versus Therapeutic Ultrasound for Sinusitis - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborator:	Sør-Trøndelag chapter of the Norwegian Physiotherapist Association
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00934830

Purpose

Question: Is the effect of therapeutic ultrasound equally effective to antibiotic for treatment of sinusitis? Design: A randomized clinical trial with concealed allocation, self-assessment by the subjects and intention-to-treat analysis.

Condition	Intervention	Phase
Sinusitis	Drug: Antibiotic (Amoxicillin) Other: Therapeutic ultrasound	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Antibiotics Versus Therapeutic Ultrasound for Treatment of Sinusitis: a Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sinusitis Ultrasound

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Pain and congestion over in forehead, around nose and pain in the teeth [ Time Frame: Day 1, 4 and 21, and one-year follow-up ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	January 2005
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Antibiotic	Drug: Antibiotic (Amoxicillin) 500 mg, 3 times per day for 10 days
Experimental: Therapeutic ultrasound	Other: Therapeutic ultrasound 1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days.

Detailed Description:

Subjects (n=48) with clinically diagnosed acute bacterial rhinosinusitis (ABRS)will included. The antibiotic group will receive amoxicillin (500 mg) 3 times per day for 10 days. The ultrasound group will receive therapeutic ultrasound over sinuses at 1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days. Improvement of symptoms (pain and congestion; numeric rating scale; 0-10) from day 1 to days 4 and 21 will be recorded. Relapses, side-effects and satisfaction with treatment will be assessed at one-year follow-up.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pain when bending forward, headache, pain in the teeth, purulent nasal secretion, "double worsening" and white blood cell count (WBC).
Patients eligible for the study had to meet one of the first three criteria (pain when bending forward, headache, pain in the teeth) and all of the other indicators (purulent nasal secretion, double worsening, a left handed displacement of lymphocytes and a right handed displacement of granulocytes on the WBC as indication of bacterial infection).
Subjects over 15 years of age were included.

Exclusion Criteria:

Subjects with any kind of antibiotic or allergic treatment within the last three weeks.
Antibiotic intolerance.
Pregnant women.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934830

Sponsors and Collaborators

Norwegian University of Science and Technology

Sør-Trøndelag chapter of the Norwegian Physiotherapist Association

Investigators

Study Chair:

Ottar Vasseljen, PhD

Norwegian Univ of Sci and Tech

More Information

Publications:

Høsøien E, Lund AB, Vasseljen O. Similar effect of therapeutic ultrasound and antibiotics for acute bacterial rhinosinusitis: a randomised trial. J Physiother. 2010;56(1):29-32.

Responsible Party:	Ottar Vasseljen, associate professor, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00934830 History of Changes
Other Study ID Numbers:	ELI-107-04(REK)
Study First Received:	July 6, 2009
Last Updated:	August 9, 2011
Health Authority:	Norway: Ethics Committee

Keywords provided by Norwegian University of Science and Technology:

Antibiotic
Ultrasound
Efficacy
Treatment

Additional relevant MeSH terms:

Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012